Notice

Release of the Therapeutic Products Directorate Statistical Report 2015/2016 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection

Health Canada is pleased to announce the release of the Therapeutic Products Directorate Statistical Report 2015/2016 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection. This report provides a statistical overview of Health Canada's administration of the Patented Medicines (Notice of Compliance) Regulations, and data protection under section C.08.004.1 of the Food and Drug Regulations.

As in previous reports, this report includes information regarding trends in the eligibility of patents for listing on the Patent Register, the eligibility of drugs for listing on the Register of Innovative Drugs, and related court activity.

Any concerns or questions regarding the contents of the report should be directed to:

Section I Overview

Overview

This document provides a statistical overview relating to the administration of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 as amended, and the data protection provisions of the Food and Drug Regulations, C.R.C., c.870 as amended by S.O.R./2006-241. The two sets of regulations are intended to act as a balanced set of measures, designed to work together to stabilize Canada's intellectual property protection for drugs by ensuring a minimum period of protection and maintaining a reasonable ceiling on the maximum protection available.

A. Patented Medicines (Notice of Compliance) Regulations

The Patented Medicines (Notice of Compliance) Regulations fall under the authority of the Patent Act which is within the mandate of Industry Canada. However, they are administered by the Office of Patented Medicines and Liaison (OPML), Office of Submissions and Intellectual Property (OSIP), Therapeutic Products Directorate, Health Products and Food Branch, Health Canada. The Patented Medicines (Notice of Compliance) Regulations came into force in March 1993 and were amended in 1998, 1999, 2006, 2008, 2010, 2011 and 2015.

According to the Regulatory Impact Analysis Statement published in Canada Gazette, Part II on October 18, 2006, the Patented Medicines (Notice of Compliance) Regulations help to balance the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors. On one end of the balance lies subsection 55.2(1) of the Patent Act, known as the "early-working" exception. Early-working allows a subsequent entry (typically generic) drug manufacturer to use a patented, innovative drug for the purpose of seeking regulatory approval to market a competing version of that drug. The Patented Medicines (Notice of Compliance) Regulations represent the other half of the balance by linking Health Canada's ability to approve a generic drug to the patent status of the equivalent innovative drug that the generic drug manufacturer seeks to copy. As such, a drug manufacturer that makes a direct or indirect comparison with, or reference to, an innovative drug in respect of which there are patents listed on the Patent Register, must either agree to await patent expiry before obtaining market authorization or make an allegation justifying immediate market entry that is either accepted by the innovator or upheld by the court.

Under the Patented Medicines (Notice of Compliance) Regulations, the OPML maintains a Patent Register that consists of patent lists submitted by drug manufacturers in respect of drugs for which market authorization has issued in the form of a Notice of Compliance. Each patent list is audited by the OPML in order to determine its eligibility under the Patented Medicines (Notice of Compliance) Regulations. As such, on behalf of the Minister of Health, the OPML may refuse to add or may delete any patent that does not meet the eligibility requirements. A web-accessible version of the Patent Register is found on the Health Canada.

In addition, the OPML ensures that patents listed on the Patent Register are addressed under the Patented Medicines (Notice of Compliance) Regulations. Detailed information on the administration of the Patented Medicines (Notice of Compliance) Regulations can be found in the guidance document: Patented Medicines (Notice of Compliance) Regulations.

B. Data Protection

The data protection provisions in section C.08.004.1 of the Food and Drug Regulations came into force in September 1995. They were amended in 2006, 2011 and 2014, in order to clarify and effectively implement Canada's obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights with respect to the protection of undisclosed tests or other data necessary to determine the safety and efficacy of a pharmaceutical product which utilizes a new chemical entity. In keeping with those obligations, innovative drugs are provided with an internationally competitive, guaranteed minimum period of market exclusivity of eight years. An additional six-month period is available for innovative drugs that have been the subject of clinical trials designed and conducted for the purpose of increasing the knowledge of the use of the drug in pediatric populations.

The data protection provisions are administered by the OPML. Innovative drugs that are eligible for data protection are listed on the Register of Innovative Drugs (RID) after the issuance of the Notice of Compliance.

C. Intellectual Property (IP) Hold

Upon completion of the review of a submission, a final intellectual property 'check' is performed by the OPML. At this stage, Health Canada has completed the scientific assessment of the safety, efficacy and quality of the drug under the Food and Drug Regulations. If the notice of compliance would be issuable but for the operation of either the PM(NOC) Regulations or data protection, the drug manufacture is so notified, and informed of the date on which the submission would have been eligible to receive a notice of compliance. The submission is then placed on an administrative hold called "Intellectual Property Hold" until all the relevant requirements regarding the PM(NOC) Regulations and data protection have been met.

Number of Patent Lists Submitted for Listing on the Patent Register

Number of Patent Lists Received

This table shows the number of patent lists received in each fiscal year, where patent lists are counted by patent per submission.

Table - Number of Patent Lists Received

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Number of patent lists received (during the fiscal year)

561

674

501

678

846

Number of Patent Lists Added to the Patent Register

This table shows the number of patent lists added to the Patent Register in each fiscal year. Note that listings do not necessarily represent new patents being added to the Patent Register for the first time. Some listings represent patents already listed on the Patent Register - for previously approved drug submissions - which have been added again in relation to a different supplement to a new drug submission. Also, patent lists may have been received in one fiscal year but not added to the Patent Register until the following fiscal year.

Table - Number of Patent Lists Added to the Patent Register

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Number of patent lists added to the Patent Register (during the fiscal year)

359

407

383

320

644

Patents not previously listed (New Drug Submission)

118

104

117

73

145

Patents not previously listed (Supplemental New Drug Submission)

108

78

79

21

123

Number of Patent Lists Rejected for Listing on the Patent Register

This table shows the number of rejected patent lists which includes patents rejected for all submissions, and not only the number of distinct patents rejected.

Table - Number of Patent Lists Rejected for Listing on the Patent Register

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

New Drug Submission (section 4(2))

25

24

14

43

15

Supplement to a New Drug Submission (section 4(3) and section 4.1(2))

72

40

45

36

49

Timing (sections 4(5) and 4(6))

11

8

11

8

20

Other

8

4

8

6

1

Total

116

76

78

93

85

A Snapshot of the Patent Register as of March 31, 2016: Number of Patents Per Drug Identification Number (DIN) on the Patent Register

This graph and table represent the number of patents that a second person is required to address when seeking a Notice of Compliance for a patented medicine. As of March 31, 2016 there were 1,384 DINs listed on the Patent Register, representing 564 different drugs. The total number of patents listed on the Patent Register is 1,010 and they are distributed per DIN. For example, there are 700 DINs which only have one patent listed against them; on the other hand, there are 8 DINs which have 19 patents listed against them. This data is product-specific, as each DIN is specific to a particular strength, route, and dosage form of a medicinal ingredient. Patents may apply to more than one DIN (for example, more than one strength, route, and dosage form of a medicinal ingredient). The numbers in the above graph do not include patents which have been removed from the Patent Register nor do they include patents which have expired prior to the generation of this report.

A Snapshot of the Patent Register as of March 31, 2016: Number of Patents per Drug Identification Number (DIN) on the Patent Register

Table - Number of Patents per Drug Identification Number (DIN) on the Patent Register

Number of Patents

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

Number of DINs

700

318

194

66

41

12

6

6

2

9

7

11

0

0

4

0

0

0

8

A Snapshot of the Patent Register as of March 31, 2016: Number of Patents Per Drug on the Patent Register

There are currently 564 different drugs listed on the Patent Register. The total number of different patents listed on the Patent Register is 1,010 and they are distributed per drug. For example, there are 272 drugs which only have one patent listed against them; on the other hand, there is one drug which has 19 patents listed against it. The numbers in the graph do not include patents which have been removed from the Patent Register nor do they include patents which have expired prior to the generation of this report.

The Patent Register is divided according to DIN in a product-specific manner. As this graph is produced by drug, some products have multiple strengths, routes, and dosage forms listed on the Patent Register while others do not.

A Snapshot of the Patent Register as of March 31, 2016: Number of Patents per Drug on the Patent Register

This table lists judicial review applications started between April 1, 2015 and March 31, 2016 and changes which took place to ongoing cases during the fiscal year. The applications were filed pursuant to section 18.1 of the Federal Courts Act with respect to decisions concerning the eligibility of patents for listing on the Patent Register under sections 3 and 4 of the Patented Medicines (Notice of Compliance) Regulations. New cases and changes to open cases which occurred during this time period are presented in bold.

This table lists judicial review applications started between April 1, 2015 and March 31, 2016 and changes which took place to ongoing cases during the fiscal year. The applications were filed pursuant to section 18.1 of the Federal Courts Act with respect to decisions concerning section 5 of the Patented Medicines (Notice of Compliance) Regulations. New cases and changes to open cases which occurred during this time period are presented in bold.

Prohibition Applications concerning section 6 of the Patented Medicines (Notice of Compliance) Regulations - Summary as of March 31, 2016

The first table shows the number of submissions with Form Vs received during a specific fiscal year and the number of Notices of Allegation received as of March 31, 2016.

The second table summarizes the outcome of applications for orders of prohibition filed in the Federal Court pursuant to Section 6 of the Patented Medicines (Notice of Compliance)Regulations (commonly referred to as prohibition applications), beginning with the number of court applications commenced by first persons. The break-down of subsequent appeals for each possible application conclusion - granted, dismissed, partially granted - is also included. The court applications commenced are the result of the Notices of Allegation made by second persons in respect of first persons' patents. The start date of the application determines the year in which the outcome is reported.

Table -Number of Submissions with Form Vs and Notices of Allegation received as of March 31, 2016

Average Time to Resolution of Prohibition Applications under the Patented Medicines (Notice of Compliance) Regulations

This table represents information regarding court cases filed pursuant to Section 6 of the Patented Medicines (Notice of Compliance) Regulations. The start date of the application determines the year in which it will be included. Average time to resolution is calculated from the start date to the close date of the application in the Federal Court (appeals not included). The 24-month period is prescribed by paragraph 7(1)(e) of the Patented Medicines (Notice of Compliance) Regulations. Pursuant to subsection 7(5), the court may make an order to vary the length of the 24-month stay.

Table - Average Time to Resolution of Prohibition Applications under the Patented Medicines (Notice of Compliance) Regulations

Prohibition Applications Exceeding a 24-Month Resolution Timeframe

This graph and table represent the number of closed applications per year which were resolved within 24 months and the number of applications which exceeded 24 months to resolve. The numbers do not include discontinued cases.

Closed Prohibition Applications

Table - Closed Prohibition Applications

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Closed within 24 months

26

21

19

8

1

Closed applications which exceeded 24 months to resolve (out of time)

0

3

0

0

0

Total number of applications closed

26

24

19

8

1

Prohibition and Judicial Review Applications

This graph and table compare the number of applications for judicial review of the Minister's decisions concerning sections 3, 4, and 5 with the number of applications for orders of prohibition with respect to section 6 of the Patented Medicines (Notice of Compliance) Regulations.

Prohibition and Judicial Review Applications Initiated Per Fiscal Year

Register of Innovative Drugs - Human Drugs

The first graph and table display the number of human drugs that were added to the Register of Innovative Drugs by Notice of Compliance date. Note that pediatric extensions for previously listed drugs may be added at a later date. The second graph and table display the number of human drugs added to the Register of Innovative Drugs by product type.

Human Drugs Added to the Register of Innovative Drugs

Table - Human Drugs Added to the Register of Innovative Drugs

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Human Innovative Drugs with Pediatric Extensions

3

5

8

8

12

Human Innovative Drugs without Pediatric Extensions

26

18

30

21

28

Total Human Drugs

29

23

38

29

40

Human Innovative Drugs by Product Type

Table - Human Innovative Drugs by Product Type

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Biologic

2

7

7

10

12

Pharmaceutical

26

16

30

19

28

Radiopharmaceutical

1

0

1

0

0

Register of Innovative Drugs - Veterinary Drugs

This graph and table display the number of veterinary drugs that were added to the Register of Innovative Drugs by Notice of Compliance date.

This table lists judicial review applications started between April 1, 2015 and March 31, 2016 and changes which took place to ongoing cases during the fiscal year. The applications were filed pursuant to section 18.1 of the Federal Courts Act with respect to decisions concerning the data protection provisions (C.08.004.1) of the Food and Drug Regulations. New cases and changes to open cases which occurred during the fiscal year are presented in bold.

Hospira Healthcare Corporation -and- The Minister of Health, The Attorney General of Canada, sanofi-aventis Canada Inc.

oxaliplatin

2013-11-28

2015-10-26

Challenge to the Minister's decision refusing to issue a Notice of Compliance on the basis that the drug triggered data protection

T-1774-14 (Dismissed)

Photocure ASA -and- The Minister of Health and The Attorney General of Canada

hexaminolevulinate hydrochloride

2014-08-19

2015-08-10

Eligibility for data protection; interpretation of "innovative drug" under C.08.004.1(1)

T-823-15(Granted on Consent)

Horizon Pharma plc -and- The Minister of Health and The Attorney General of Canada

glycerol phenylbutyrate

2015-05-20

2015-12-10

Eligibility for data protection; interpretation of "innovative drug" under C.08.004.1(1)

Judicial Review Applications

This graph and table represent the number of court proceedings with respect to data protection under (C.08.004.1) of the Food and Drug Regulations.

Judicial Review Applications Initiated Per Fiscal Year

Table -Judicial Review Applications Initiated Per Fiscal Year

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Judicial Reviews

0

1

1

1

1

Judicial Review Appeals

0

0

0

0

0

Section IV Statistics: Intellectual Property (IP) Hold

Submissions Previously on Intellectual Property (IP) Hold

The first graph and table show the number of submissions that previously had been on IP Hold and are now cleared by the fiscal year in which they received their Notice of Compliance. The second graph and table show the average time, in days, that these submissions spent on IP Hold.

Number of Submissions Previously on IP Hold by Notice of Compliance Date

Table - Number of Submissions Previously on IP Hold by Notice of Compliance Date

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Number of Submissions

188

132

105

134

179

Average Number of Days on IP Hold by Fiscal Year in which Notice of Compliance was Issued

Table -Average Number of Days on IP Hold by Fiscal Year in which Notice of Compliance was Issued

Fiscal Year

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Number of Days

313

437

494

402

300

Submissions Remaining on IP Hold

This graph and table show the number of submissions by fiscal year filed which were still on IP Hold as of March 31, 2016.

Submissions Remaining on IP Hold by Fiscal Year Filed

Table -Submissions Remaining on IP Hold by Fiscal Year Filed

Fiscal Year

2007/2008

2008/2009

2009/2010

2010/2011

2011/2012

2012/2013

2013/2014

2014/2015

2015/2016

Number of Submissions Remaining on IP Hold

5

2

7

6

10

27

29

40

52

Appendix A Definitions

Defnitions

Court:

The Federal Court of Canada or any other superior court of competent jurisdiction.

Discontinued:

The cessation of court proceedings where the applicant voluntarily puts an end to the case, with or without leave of the court.

Dismissed:

The removal of a case from court, the termination of a case before trial or before a complete trial. In the case of the Patented Medicines (Notice of Compliance) Regulations, however, the dismissal indicates a decision at any point in the matter, either summary, as a result of a motion, or at the end of the proceeding following arguments (hearing).

Drug Identification Number (DIN):

A Drug Identification Number is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada.

First Person:

The person referred to in subsection 4(1) of the Patented Medicines (Notice of Compliance) Regulations, typically a brand name drug manufacturer.

Innovative Drug:

A drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (C.08.004.1 (1), Food and Drug Regulations)

Intellectual Property (IP) Hold:

The period of time when, upon completion of the review of a submission, a Notice of Compliance would be issuable but for the provisions of the Patented Medicines (Notice of Compliance) Regulations and/or data protection provisions under section C.08.004.1 of the Food and Drug Regulations.

Notice of Allegation:

A notice issued under section 5 of the Patented Medicines (Notice of Compliance)Regulations. Such notices set out the nature of the generic manufacturer's challenge to a patent listed on the Patent Register.

Notice of Compliance:

Market authorization issued under section C.08.004 of the Food and Drug Regulations.

Patent List:

Form IVs submitted by the first person pursuant to section 4 of the Patented Medicines (Notice of Compliance) Regulations.

Patent Register:

The register of patents and other information maintained by the Minister in accordance with subsection 3(2) of the Patented Medicines (Notice of Compliance) Regulations.

Pending:

A court case awaiting judgment.

Prohibition Granted:

An order of prohibition which prevents the Minister from issuing a Notice of Compliance.

Prohibition Partially Granted:

An order of prohibition applying to one or more but not to all patents that are the subject of a case under section 6 of the Patented Medicines (Notice of Compliance)Regulations where more than one patent is at issue.

Register of Innovative Drugs

The register maintained by the Minister in accordance with section C.08.004.1(9) of the Food and Drug Regulations.

Second Person:

The person referred to in section 5 of the Patented Medicines (Notice of Compliance) Regulations, typically a generic drug manufacturer.

Submission:

Any or all of: a new drug submission (NDS); an abbreviated new drug submission (ANDS); a supplement to a new drug submission (SNDS); a supplement to an abbreviated new drug submission (SANDS); and an extraordinary use new drug (EUNDS).